US9039726B2 - Filamentary devices for treatment of vascular defects - Google Patents
Filamentary devices for treatment of vascular defects Download PDFInfo
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- US9039726B2 US9039726B2 US12/911,034 US91103410A US9039726B2 US 9039726 B2 US9039726 B2 US 9039726B2 US 91103410 A US91103410 A US 91103410A US 9039726 B2 US9039726 B2 US 9039726B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12159—Solid plugs; being solid before insertion
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A—HUMAN NECESSITIES
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
- A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12068—Details concerning the detachment of the occluding device from the introduction device detachable by heat
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- A—HUMAN NECESSITIES
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- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
- A61B2018/00416—Treatment of aneurisms
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- A—HUMAN NECESSITIES
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3966—Radiopaque markers visible in an X-ray image
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
- Y10T156/1051—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina by folding
Definitions
- the present invention is directed to braid-balls suitable for aneurysm occlusion and/or parent vessel occlusion/sacrifice (e.g., in treating neurovascular defects).
- the form of the ball is very important.
- the density of the device is paramount in applications where braid itself is intended to moderate or stop blood flow—allowing thrombosis within a volume formed by the ball.
- braid-ball type implants are provided in braid of sufficient density is provided to moderate blood flow within the volume of the implant. Upon thrombosis, flow thereto is stopped.
- a blood-barrier covering can be applied to the filamentary structure to immediately stop blood flow into the vascular site, in which the implant volume is set.
- the filaments of the braid matrix permit filling of the implant with blood when emplaced at a vascular treatment site. This blood then thromboses due to the flow-disruption effect(s).
- the ball devices are adapted to work alone—or in combination with each other to effect a complete treatment.
- high density braid/mesh is typically required. Namely, braid having at least about 48 ends, typically set at about 90 degrees or greater, in diameters from about 4 to about 8 mm may be employed. At larger diameters (e.g., about 6 to 12 or more), more wire ends (e.g., 64, 72 and upwards) may be employed in forming the balls.
- Suitable braid for constructing the balls may be obtained from Secant Medical, Inc. Wire diameters may be in the range of about 0.001 to about 0.003 inches, depending on desired delivery profile (which is typically less than about 0.050 inches).
- the braid forming the balls may incorporate only one size wire, or may be formed with multiple sizes.
- the wire is preferably superelastic NiTi alloy.
- the metal may be a binary alloy or a ternary alloy to provide additional radiopacity.
- radiopaque platinum fibers may be included in the braid, or the wire may comprise platinum or gold cord Nitinol DFT. Otherwise, wraps or bands (preferably Pt) used to secure the braid wire may serve as the sole radiopaque feature(s).
- the construction approaches described herein enable producing these useful devices. Whether comprising braid alone, or incorporating some further blood-barrier covering (such as a thin urethane film as may be applied by Hantel, Inc. or others) the use of braid presents numerous challenges in managing the termination of multiple wires and in forming the desired structures.
- detachable implant pushers that utilize a resistance wire heater to thermally sever a suture associated with the implant to effect release.
- the present invention contemplates a leave-behind tether.
- FIG. 1 is a photograph taken from U.S. Provisional Patent Appl. No. 61/046,670 (incorporated herein by reference) demonstrating actual reduction to practice of a single-layer braid ball device made according to the present invention
- FIGS. 2A and 2B are side-sectional views of the braid ball in isolation and in use, respectively;
- FIG. 3 illustrates a suture-melt resistance heater pusher for implant delivery
- FIGS. 4A-4F illustrate a production path of one implant embodiment encompassed by the current invention.
- a filamentary implant 2 is formed out of braid to treat vascular sites.
- Interwoven filaments 4 form a braid matrix 6 that define a self-expandable occlusion device.
- ties 10 as illustrated in FIG. 1
- bands 12 as illustrated in FIGS. 2A and 2B .
- the expanded configuration defines an ovoid or roughly spherical shell 18 that is permeable to blood.
- the braid defining the proximal and distal ends of the implant turns or curves inward to a point where it is secured within the periphery of the shell.
- the inversion of the braid provides recessed securement of the braid resulting in atraumatic ends of the implant.
- the braid filaments optionally extend beyond the securing/securement features in order to define wire filament “tufts” 20 that will further promote thrombosis of blood that enters the ball upon deployment within a patient's vasculature.
- inset ends of the braid are demonstrated when the implant is in an expanded state to fill an aneurysm 26 off of a vessel 28 .
- FIG. 3 illustrates a detachable catheter/pusher 30 , optionally, for use in the present invention.
- it includes a resistance wire bridge 32 across insulated conductors 34 (a typical construction). What is unique is that the conductor wires are twinned/twisted along a length of the delivery pusher shaft 38 as shown. This configuration alleviates bending bias/preference.
- the tip thermally severs the polymer filament (e.g., suture 40 ) in contact therewith. At least the suture portion is received within the implant 2 (e.g., passing through a braid-securing band 12 ). The suture is retained in/with the implant upon actuation to release the implant by cutting through the suture with heat.
- polymer filament e.g., suture 40
- a ball stop 42 that is tied to the suture retains the filament in/with the implant is also illustrated.
- pusher 30 is shown received within a typical microcatheter 44 for vascular access, after passage therethough. Note also, other advantageous delivery system are referenced and described in the incorporated patent application.
- the intention is a method of manufacture including tying-off or otherwise securing a second end of a braid within an interior volume of a ball where other approaches would be impracticable.
- the technique may be employed in creating the balls (be they spherical or ovaloid in cross-section, etc.) out of one continuous section of braid. In so doing, joints and other delivery profile-increasing features are avoided—as well as potential areas for failure. Accordingly, the subject implants are extremely robust and fully recoverable to their aneurysmal shape as is required when they are delivered through a catheter in low profile. Robust shape recovery is required in treatments targeting distal vasculature, especially the tortuous neurovasculature encountered in human brains.
- FIGS. 4A-4F A detailed example of one process path for implant formation is illustrated in FIGS. 4A-4F .
- an final implant 2 may begin as a section 50 of braided material.
- the tubular braid stock is secured. As shown, it is tied-off with a wire wrap 10 . Such action develops an inset region 24 for the implant body.
- An opposite end of the braid is then captured in a transfer tube 52 .
- the tube is passed through the volume of the implant and secured with a second tie 10 at the other side.
- Additional refinement to the shape over that shown in FIG. 4E may be imparted within a shape-setting form 54 .
- Mandrels 56 including stops 58 received through the securement features may be employed to force apposition of the ball to the shape of the form when pulled apart as indicated by arrows.
- shape-setting in the form as appropriate to the selected material—e.g., as in heat setting superelastic Nitinol
- the mandrels are removed and the implant shaping is complete as shown in FIG. 4F .
- these additional forming steps are not necessary given that (in point of fact) the implant in FIG. 1 was produced without employing the same.
- any one of the subject implants is delivered to a target site employing known percutaneous catheter access techniques.
- the implant may be secured to a pusher (e.g., pusher 30 ) used to advance it through the access catheter (e.g., microcatheter 44 ).
- the implant Upon emplacement at the treatment site (e.g., cerebral aneurysm 26 as illustrated in FIG. 2A ), the implant can be detached.
- the suture 40 passing through the proximal end of the implant 2 is severed by melting it using a resistance heater. This retention/release fiber remains in and with the implant.
Abstract
Description
Claims (21)
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/911,034 US9039726B2 (en) | 2008-04-21 | 2010-10-25 | Filamentary devices for treatment of vascular defects |
US13/470,013 US9585669B2 (en) | 2008-04-21 | 2012-05-11 | Multiple layer filamentary devices for treatment of vascular defects |
US15/415,669 US20170156733A1 (en) | 2008-04-21 | 2017-01-25 | Multiple layer filamenyary devices for treatment of vascular defects |
US16/893,431 US20200367904A1 (en) | 2008-04-21 | 2020-06-04 | Multiple layer filamentary devices for treatment of vascular defects |
US17/408,329 US11844528B2 (en) | 2008-04-21 | 2021-08-20 | Multiple layer filamentary devices for treatment of vascular defects |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4659408P | 2008-04-21 | 2008-04-21 | |
US4667008P | 2008-04-21 | 2008-04-21 | |
US8396108P | 2008-07-28 | 2008-07-28 | |
US8395708P | 2008-07-28 | 2008-07-28 | |
US14509709P | 2009-01-15 | 2009-01-15 | |
US12/427,620 US8142456B2 (en) | 2008-04-21 | 2009-04-21 | Braid-ball embolic devices |
US12/911,034 US9039726B2 (en) | 2008-04-21 | 2010-10-25 | Filamentary devices for treatment of vascular defects |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/427,620 Continuation US8142456B2 (en) | 2008-04-21 | 2009-04-21 | Braid-ball embolic devices |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/470,013 Continuation US9585669B2 (en) | 2008-04-21 | 2012-05-11 | Multiple layer filamentary devices for treatment of vascular defects |
Publications (2)
Publication Number | Publication Date |
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US20110208227A1 US20110208227A1 (en) | 2011-08-25 |
US9039726B2 true US9039726B2 (en) | 2015-05-26 |
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Family Applications (12)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/427,620 Active 2030-08-27 US8142456B2 (en) | 2008-04-21 | 2009-04-21 | Braid-ball embolic devices |
US12/427,635 Abandoned US20090287291A1 (en) | 2008-04-21 | 2009-04-21 | Embolic Device Delivery Systems |
US12/911,034 Active US9039726B2 (en) | 2008-04-21 | 2010-10-25 | Filamentary devices for treatment of vascular defects |
US13/048,648 Active 2029-05-08 US8747597B2 (en) | 2008-04-21 | 2011-03-15 | Methods for making braid-ball occlusion devices |
US13/470,013 Active 2032-05-20 US9585669B2 (en) | 2008-04-21 | 2012-05-11 | Multiple layer filamentary devices for treatment of vascular defects |
US13/477,833 Abandoned US20120330347A1 (en) | 2008-04-21 | 2012-05-22 | Multiple Layer Filamentary Devices for Treatment of Vascular Defects |
US13/610,721 Abandoned US20130066360A1 (en) | 2008-04-21 | 2012-09-11 | Braid-Ball Embolic Devices |
US13/631,470 Active US8696701B2 (en) | 2008-04-21 | 2012-09-28 | Braid-ball embolic devices |
US13/664,348 Abandoned US20130123830A1 (en) | 2008-04-21 | 2012-10-30 | Multiple Layer Filamentary Devices for Treatment of Vascular Defects |
US15/415,669 Abandoned US20170156733A1 (en) | 2008-04-21 | 2017-01-25 | Multiple layer filamenyary devices for treatment of vascular defects |
US16/893,431 Pending US20200367904A1 (en) | 2008-04-21 | 2020-06-04 | Multiple layer filamentary devices for treatment of vascular defects |
US17/408,329 Active 2029-07-20 US11844528B2 (en) | 2008-04-21 | 2021-08-20 | Multiple layer filamentary devices for treatment of vascular defects |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/427,620 Active 2030-08-27 US8142456B2 (en) | 2008-04-21 | 2009-04-21 | Braid-ball embolic devices |
US12/427,635 Abandoned US20090287291A1 (en) | 2008-04-21 | 2009-04-21 | Embolic Device Delivery Systems |
Family Applications After (9)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/048,648 Active 2029-05-08 US8747597B2 (en) | 2008-04-21 | 2011-03-15 | Methods for making braid-ball occlusion devices |
US13/470,013 Active 2032-05-20 US9585669B2 (en) | 2008-04-21 | 2012-05-11 | Multiple layer filamentary devices for treatment of vascular defects |
US13/477,833 Abandoned US20120330347A1 (en) | 2008-04-21 | 2012-05-22 | Multiple Layer Filamentary Devices for Treatment of Vascular Defects |
US13/610,721 Abandoned US20130066360A1 (en) | 2008-04-21 | 2012-09-11 | Braid-Ball Embolic Devices |
US13/631,470 Active US8696701B2 (en) | 2008-04-21 | 2012-09-28 | Braid-ball embolic devices |
US13/664,348 Abandoned US20130123830A1 (en) | 2008-04-21 | 2012-10-30 | Multiple Layer Filamentary Devices for Treatment of Vascular Defects |
US15/415,669 Abandoned US20170156733A1 (en) | 2008-04-21 | 2017-01-25 | Multiple layer filamenyary devices for treatment of vascular defects |
US16/893,431 Pending US20200367904A1 (en) | 2008-04-21 | 2020-06-04 | Multiple layer filamentary devices for treatment of vascular defects |
US17/408,329 Active 2029-07-20 US11844528B2 (en) | 2008-04-21 | 2021-08-20 | Multiple layer filamentary devices for treatment of vascular defects |
Country Status (14)
Country | Link |
---|---|
US (12) | US8142456B2 (en) |
EP (9) | EP3970633A1 (en) |
JP (1) | JP5610542B2 (en) |
CN (3) | CN102014769B (en) |
AT (1) | ATE533414T1 (en) |
AU (1) | AU2009239424B9 (en) |
CA (1) | CA2722037C (en) |
DK (1) | DK2265193T3 (en) |
EA (1) | EA201071225A1 (en) |
ES (4) | ES2430117T3 (en) |
IL (1) | IL208659A0 (en) |
SG (1) | SG189809A1 (en) |
WO (1) | WO2009132045A2 (en) |
ZA (1) | ZA201007444B (en) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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